Seabreeze STAT COPD

Currently Recruiting: Sites and Participants

Study Drug/Intervention: Rademikibart

Anticipated Sample Size: 160 participants

Study Timeline: This study is expected to recruit through September 2026.

ClinicalTrials.gov ID: NCT06940154

What is Seabreeze STAT COPD?

Participants with COPD exhibiting the eosinophilic phenotype who are undergoing an acute exacerbation (flare-up) have an increased risk of subsequent exacerbations. The study is testing whether a potential new medication, rademikibart, when added to standard COPD treatment during a flare-up, can improve healthcare outcomes in this participant population by focusing on drug delivery timing during flare-ups in a population with an eosinophilic phenotype. Participants will be consented and screened to participate in Channel 1 while in stable condition, or in Channel 2 during an urgent health care visit for an acute COPD exacerbation. Approximately 160 participants will be randomized in a 1:1 ratio for rademikibart or placebo to evaluate the treatment failure rate within 28 days after randomization.

Study Objective

To assess the efficacy, safety, and subsequent COPD exacerbations of rademikibart versus placebo, when administered as an adjunct to standard therapy following randomization in participants with COPD and an eosinophilic phenotype experiencing an acute COPD exacerbation (flare up).

Inclusion Criteria

• Adults (40 to 80 years, inclusive) at the time of signing the informed consent
• Body weight of ≥45 kg and body mass index within the range 16 to 35 kg/m2 (inclusive) at screening
• Physician-diagnosed COPD with duration of ≥12 months
• Must have experienced at least 1 COPD exacerbation requiring the use of systemic corticosteroids (oral or parenteral) within the previous 12 months prior to screening
• Documented blood eosinophil count (EOS) ≥250 cells/μL for Channel 1 participants
• Current or former smoker with a history of smoking of ≥10 pack-years
• Acute exacerbation requiring an urgent healthcare visit with EOS of ≥300 cells/μL at time of current exacerbation (for all participants)
• Requires systemic corticosteroids as standard of care treatment for current acute COPD exacerbation

Exclusion Criteria

• Regular use of immunosuppressive medication or a history of immunosuppression
• Receipt of any marketed or any investigational biologic for COPD or other diseases ≤16 weeks or ≤5 half-lives prior to randomization
• Treatment with oral corticosteroids and/or hospitalization for an exacerbation of COPD was completed <4 weeks prior to randomization.
• Chronic treatment with long-term or nocturnal oxygen therapy is required for> 15 hours a day.
• Receiving long-term macrolide therapy
• Diagnosis/history of asthma or Asthma COPD Overlap Syndrome
• Chest X-ray/CT scan reveals clinically significant non-COPD abnormalities or pulmonary infection
• Unstable ischemic heart disease, cardiomyopathy, heart failure, uncontrolled hypertension, cardiac arrhythmias, including paroxysmal atrial fibrillation. Transient ischemic attack or stroke <6 months
• Hospitalization for any cardiovascular or cerebrovascular event <6 months

Adult participants (40 to 80 years, inclusive) with COPD characterized by an eosinophilic phenotype who require an urgent healthcare visit for treatment of an acute exacerbation. There are two different channels for enrollment (consenting and screening):

1. While in a stable condition (awaiting acute exacerbation for ≤26 weeks)
2. At an urgent healthcare visit for an acute COPD exacerbation

Study Sites

For a list of active recruiting centers, please visit ClinicalTrials.gov NCT06940154

Duration of Study Participation

Channel 1: Screening period of up to 26 weeks plus 48 hours

Channel 2: Screening period of up to 48 hours

Both Channels: 28-day treatment assessment period and 28-day follow-up period

Connect Biopharma

DCRI Seabreeze COPD study email: DCRI-Seabreeze-COPD@duke.edu